Regulatory Focus™ > News Articles > Regulatory Recon: FDA Still Trying to Gets its Inspectors into China (17 November 2014)

Regulatory Recon: FDA Still Trying to Gets its Inspectors into China (17 November 2014)

Posted 17 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Still Trying to Gets its Inspectors into China (17 November 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • Thalidomide: how men who blighted lives of thousands evaded justice (Guardian)
  • More Information About EMA's New Leader, Andreas Pott (EMA)
  • Most European hospitals face medicines shortages (PMLive)
  • Special marks on packs proposed to identify essential drugs (India Times) (India Times)
  • Sterilization deaths expose India's struggle with faulty drugs (Reuters)
  • Corruption tars drug industry drive to improve access for poor (Reuters) (Guardian) (FT-$) (PMLive)

US: Pharmaceuticals and Biotechnology

  • Genzyme’s MS Drug Lemtrada Approved by the FDA (Press) (Boston Herald) (BioFlash) (Reuters) (Fierce) (WSJ-$) (MS Discovery) (Pharma Times)
  • Roche's Avastin wins FDA green light in ovarian cancer (Fierce) (MPR) (Press) (MedPage Today) (SCRIP-$) (BioCentury) (Reuters)
  • Colorado Health Department to Recommend ‘Premarket Approval’ for Edible Marijuana (NYTimes)
  • AIDS Group Wages Lonely Fight Against Pill to Prevent H.I.V. (The Upshot)
  • FDA Revises Internal Policy on Allowing Emergency IND Applications (FDA)
  • Will The DSCSA Cause Drug Shortages After January 1? (RxTrace)
  • Rx vs OTC- the Debate Continues (Lachman)
  • Eli Lilly's VP of Global RA: "FDA should develop a multi-year pilot program to explore the science of patient input in benefit/risk assessment" (PhRMA)
  • Sun Pharma recalls 68,194 bottles of anti-depression drug in US (India Times) (FDA) (LiveMint)
  • US FDA seeks additional data from Kremers Urban Pharmaceuticals' methylphenidate ER tablets (PharmaBiz)
  • Diabetes Endpoints, CV Requirements Get Special Handling At FDA-Patient Meeting (Pink Sheet-$)
  • Pliva Asks High Court To Review Generic Drug Ruling (Law 360-$)
  • House of Representatives to Hear FDA Testimony on Ebola Product Development (House)
  • Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory? (Adverse Events)
  • Alexion’s Soliris REMS Working Well But Might Benefit From Small Changes (Pink Sheet-$) (Tarius)
  • FDA to Revoke NDAs for 13 Products, Citing Failure to Submit Annual Reports (FDA News-$) (FDA)
  • Toxicity Database Collaboration Between EPA, FDA Could Be Boon for Computational Toxicology Efforts (Genome Web-$)
  • Express Preemption for OTC Drugs (D&D Law)
  • Spain's Grifols' U.S. plasma installation cleared by FDA (Reuters)
  • Solgar, Inc. Issues Voluntary Class I Recall of Powder (FDA) (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Surprise: Merck's cholesterol combo Vytorin hits goal in long-awaited outcomes trial (Fierce) (Press) (Forbes) (Bloomberg)
  • Novartis Arthritis Drug Generates Positive Late-Stage Trial Results (WSJ-$) (PharmaPhorum)
  • FDA Accepts Actavis' Bipolar Drug sNDA (Press)
  • FDA acceptance of sNDA for SAPHRIS (asenapine) for the treatment of bipolar I disorder in pediatric patients announced (Press)
  • Pernix Submits sNDA for TREXIMET Use in Adolescent Patients (Press)
  • Amicus Drug Improves Marker of Heart Health in Fabry Patients (The Street)
  • Bristol-Myers immunotherapy shows promise to replace chemo for melanoma (Reuters) (Press) (Fierce) (SCRIP-$) (WSJ-$)
  • MSD Announces Positive Study Investigating the Use of Pembrolizumab Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma (Press)
  • AstraZeneca's PhIII gout data for lesinurad includes a hit, a strikeout and a missing player (Fierce) (Press)
  • Keryx announces results from ferric citrate phase 3 long-term safety extension study (Press)
  • AstraZeneca lupus drug produces positive results in trial (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Federal Investigation Into Painkillers Targets N.F.L. Teams’ Medical Staffs (NYTimes)
  • Kentucky Drops Two-Drug Execution Method (AP)
  • US Capitol Capsule: Forget Sovaldi; generics new pricey drugs poster child (SCRIP-$)
  • Patent Trolls Eye Biotech Firms; New PTO Proceedings Are ‘Game Changer’ (Pink Sheet-$)

US: Medical Devices

  • MDMA Founding Chair Tommy Thompson Dies At 76 (Fierce)
  • Philips Healthcare Announces Recall of Children’s Medical Ventures Gel-E Donut / Squishon 2 Products (FDA)
  • Syneron Candela Expands Capabilities of UltraShape Non-Invasive Fat Destruction Platform, Receives FDA Clearance for the New U-Sculpt Transducer and Enhanced Ultrasound Power (Press)
  • Class I Recall for Walker/Rolling Chair (FDA)
  • Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons (FDA)

US: Dietary Supplements

  • FDA Developing Electronic Portal for NDI Notifications (NPI) (FDA)
  • Does The Practice Of Having A Weight Range Of 95% - 105% Produce A Misbranded Product For Class I Nutrients? (Dietary Supplement Experts)
  • FDA files injunction against sports supplement manufacturer over years-long record of GMP failures (Nutra Ingredients)
  • Chaotic Labz Issues Voluntary Nationwide Recall of Mayhem Dietary Supplement Due to Undeclared Dexamethasone and Cyproheptadine (FDA)

US: Assorted And Government

  • FDA says expects China to OK staff visas after two-year delay (Reuters) (ECN) (Bloomberg)
  • How Far Does FDA’s Say-So Travel? (FDA Law Blog)
  • FDA Regulatory Requirements, Enforcement Activity Have Increased Despite Agency Acknowledging the Strain on Small Companies (Policy and Medicine)
  • FDA Weekly Enforcement Report (FDA)

Upcoming Meetings

Ebola Outbreak

  • WHO panel: Prioritize drugs for Ebola efficacy trials (SCRIP-$)
  • WHO starts survey of Ebola treatments, says none proven so far (Reuters) (AP)
  • No safety concerns yet in trials of GSK's Ebola vaccine (Reuters)
  • Device Maker Says Ebola Patient Recovered After Blood Filtration (Xconomy)
  • Canada begins domestic trial of experimental Ebola vaccine (Reuters)
  • Ebola Vaccine Challenge: Motorbikes and Kerosene Fridges (Bloomberg)

Europe

  • Thalidomide: how men who blighted lives of thousands evaded justice (Guardian)
  • More Information About EMA's New Leader, Andreas Pott (EMA)
  • How to get a headstart with clinical evidence requirements for new EU IVD Reg (Clinica-$)
  • EMA, FDA Officials Meeting to Further GMP Inspection Cooperation (EMA)
  • Most European hospitals face medicines shortages (PMLive)
  • Two Affy Partners Launch Tests in Europe, Intensify Talks with FDA to Bring Dxs to US (GenomeWeb)
  • Internationally health economic evaluations are a fixed component of reimbursement decisions, says IQWiG (PharmaLetter-$)
  • Public consultation of the draft methodological guideline “Methods for health economic evaluations” (EUnetHTA)

India

  • Special marks on packs proposed to identify essential drugs (India Times) (India Times)
  • Sterilisation deaths: drug company had faced action earlier (Business Standard)
  • Sterilization deaths expose India's struggle with faulty drugs (Reuters)
  • Indian State Recalls Pills Linked to Sterilization Deaths (NYTimes)
  • Drug Maker Arrested in India Sterilization Deaths (AP)
  • Rat poison linked to India sterilisation deaths, with death toll expected to rise (Guardian) (Reuters)
  • Top-selling 100 drugs to get cheaper soon (India Times)
  • India's fixed-dose combo problem: Too much of a good thing? (BioPharma Dive)
  • Insight On India – Highlights From The Week Of Nov 9-15, 2014 (TwoFour Insight)

Other International

  • Corruption tars drug industry drive to improve access for poor (Reuters) (Guardian) (FT-$) (PMLive)
  • Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels (IPQ-$)
  • For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Amendment 3 to the Asian Harmonization Working Party House Rules” (AHWP)
  • For endorsement at the 19th AHWP Meeting-PROPOSED FINAL document on "Comparison between the Common Submission Dossier Template (CSDT) format and the GHTF Summary Technical Documentation (STED) formats for In Vitro Diagnostic Medical Devices" (AHWP)

General Regulatory And Interesting Articles

  • ‘Tweens’ most likely to misuse over-the-counter meds (Reuters)
  • Don’t Slow Your EQMS Adoption Roll (Pharma Manufacturing)
  • When Treating ADHD, Should Children be Given One Drug or Two? (NYTimes)
  • Semen Protects HIV From Microbicide Attack (Scientific American)
  • How Bacteria In The Gut Help Fight Off Viruses (NPR)
  • What kills us, in one chart (Vox)
  • Some Humor on the Use of Control Groups (PharmaGossip)

Regulatory Reconnaissance #442 – 17 November 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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